TAR-0520 Gel in EGFR Inhibitor-induced Folliculitis

A Phase II Multicentric, Randomized, Double-blind, Placebo-controlled Study of TAR-0520 Gel in EGFR Inhibitor-induced Folliculitis.

A Phase II, multicentric, randomized, double-blind, placebo-controlled, parallel- group trial to confirm the good safaty profile and to explore the preventive effect of topically applied TAR-0520 gel on folliculitis developed in metastatic colorectal cancer (mCRC) patients treated with monoclonal anti-EGFR antibodies.

Study Overview

• Status: Recruiting
• Conditions: EGFR Inhibitor-associated Rash
• Intervention / Treatment: Drug: Brimonidine tartrate Gel; Drug: Placebo gel (no Brimonidine tartrate)

Detailed Description

Cetuximab and panitumumab hae become the standard treatment for patients with metastatic colorectal cancer without RAS gene mutation. Hoever, these EGFR inhbitors induce a broad spectrum of cutaneous toxicities (skin side effects) in 75-90% of patients, including the folliculitis involving the face,upper torso and scalp. The folliculitis appears within 1-2 weeks of anti-EGFR therapy and peaks around 3-5 weeks of treatment. There is no approved treatment to prevent or treat EGFR-induced folliculitis. Tarian Pharma has developed a new topical treatment of EGFRi-induced folliculitis.This study aims to confirm the good safety of TAR-0520 gel in colorectal cancer patients treated with cetuximab or panitmumab and eplore , in the same patients , the effect of TAR-0520 gel on the extent and severity of EGFRi-induced folliculitis.

Patients aged 18 years and over with metastatic colorectal carcinoma planned to be treated with cetuximab or panitumumab injections will be included in the study.

Participants will be randomly allocated to receive either the topical active TAR-0520 gel or its vehicle.The study will include a 7days treatment period with once daily applications of the test product followed by a treatment free period until the start of the next chemotherapy cycle usually 7 days later.The study will cover 4 complete chemotherapy cycles, thus lasting at least 56 days.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Janusz Czernielewski, MD; Phone Number: +33680338274; Email: janusz.czernielewski@tarianpharma.com
• Study Contact Backup: Name: Alexandra Lamquin, PhD; Email: alexandra.lamquin@tarianpharma.com

Study Locations

• France
  • Lyon, France, 69008
    • Recruiting
    • Hôpital Privé Jean Mermoz
    • Contact: Pascal Artru, MD
    • Contact: Pascal Artru, MD; Phone Number: +33437538726; Email: dr.artru@wanadoo.fr
  • Marseille, France, 13273
    • Recruiting
    • Institut Paoli Calmette
    • Contact: Emmanuel Mitry, MD; Phone Number: +33 491223302; Email: mitryje@ipc@unicancer.fr
    • Contact: Emmanuel Mitry, MD
  • Nice, France, 06189
    • Not yet recruiting
    • Centre Antoine Lacassagne
    • Contact: Ludovic EVESQUE, MD
    • Contact: Ludovic Evesque, MD; Phone Number: +33 492031352; Email: ludovic.evesque@nice.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• male or female, who is at least 18 years of age or older at the screening visit
• patients with clinical diagnosis of metastatic colorectal carcinoma planned to be treated with cetuximab or panitumumab injections as part of the chemotherapy protocol
• patients who can understand and sign the Informed Consent Form, can communicate with investigator,can understand and comply with requierements of the protocol, and can apply the study gel by himself/herself or have giver who can apply the product
• patients with predicted life expectency of > 3 months
• patients willing and able to comply with all of the time commitements and procedural requirements of the clinical trial protocol

Exclusion Criteria:

• patients with medical history of EGFR treatment in the past 2 years
• patients with any underlying physical ,psychological or medical condition that, in the opinion of the invstigator, would make it unlikely that the patient will comply with the protocol or complete the study protocol
• patients with any uncotrolled or serious disease, or any medical or surgical condition,that may put the subject at significant risk (according to the investigator's judgement) if he/she participates in the clinical trial
• patients with history of other skin disorders (eg.atopic dermatitis,psoriasis,recurrent skin infections), or a history of illness that, in the opinion of the investigator, would confound the results of the study
• patients with significant skin disease other than EGFRi-induced folliculits within the same body areas planned for study drug application
• patients with a beard that would interfere with administration of the study drug and assessement of study endpoints
• patients with active infection within the treatment area ot in other body areas that requieres initiation of systemic antibiotics
• patients with known or suspected allergies or sensitivities to any components of the study drugs
• female patients who are pregnant or lactating

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo arm	Drug: Placebo gel (no Brimonidine tartrate); Once daily applications for 7 days
Experimental: Active arm; Brimonidine tartrate gel	Drug: Brimonidine tartrate Gel; Once daily applications for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Treatment - emergent Advers Events (TEAEs)	TEAEs will be tabulated in frequency tables by System Organ Class and Preferred Term, based on the Medical Dictionary for Regulatory Activities (MedDRA). Additional summary tables will be provided for AEs that are considered serious (SAEs), related to the study drug, adverse events of special interest (AESIs), and AEs leading to discontinuation. The safety conclusions will be based on the comparative analysis of the AEs reported in the two treatment arms.	At Baseline and then at Day 14, Day 28, Day 42 and Day 56 .

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of TAR-0520 gel to prevent EGFR-induced folliculits	The preventive effectivness of TAR-0520 gel will be measured by assessing EGFR-induced folliculitis severity using a modified Common Terminology Criteria for Adverse Events (CTCAE) scale (Grade 0-no folliculitis - Grade 4-severe folliculitis)	The measurements will be performed at Baseline visit and then at Day 14,Day 28,Day 42 and Day 56.

Collaborators and Investigators

• Sponsor: Tarian Pharma

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: EGFR inhibitor-induced skin rash;; EGFR inhibitor-induced folliculitis
• Additional Relevant MeSH Terms: Skin Diseases; Hair Diseases; Folliculitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Antihypertensive Agents; Brimonidine Tartrate
• Other Study ID Numbers: TARIAN 007; 2024-516339-28-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No